Supreme Court Finds Certain Pharmaceutical Failure-to-Warn Claims Not Preempted

January 1, 0001


In a decision issued on March 4, 2009, the Supreme Court resolved the “narrow question” of “whether federal law pre-empts [a plaintiff’s] claim that [the defendant’s prescription drug] Phenergan’s label did not contain an adequate warning about using the IV-push method of administration.” See Wyeth v. Levine, No. 06-1249, slip. op. at 8, 25 (Mar. 4, 2009). In an opinion written by Justice Stevens, five members of the Court rejected the drug-manufacturer defendant’s assertion of conflict pre-emption, which applies when state law either (1) makes it impossible to comply with federal law, or (2) stands as “as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941); see Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963).


To begin, the Wyeth majority rejected the defendant’s argument that it was impossible to comply with the state-law duty to warn because the defendant could not change the label of its drug without first obtaining approval from the FDA, which generally must pre-approve prescription drug labels. See slip op. at 11-17. Instead, the Court relied upon a regulation that, in certain circumstances, permits a manufacturer to change an approved label before obtaining FDA approval. Id. at 11, 12 (citing 21 C.F.R. §§ 314.70(C)(6)(iii)(A), (C) (the “CBE regulation”); 73 Fed. Reg. 49609). The Court concluded on the facts before it that the defendant manufacturer could have “added a stronger warning about IV-push administration” of Phenergan, because the company could have “analyzed . . . accumulating data” to conclude that a stronger warning was necessary. Id. at 12. That relabeling, the Court explained, would not have made Phenergan a “new drug” or misbranded the drug in violation of federal law. Id. at 13. Although the Court recognized that the “FDA retains authority to reject labeling changes” made by a manufacturer under the CBE regulation, the Court was unwilling, “absent clear evidence that the FDA would not have approved a change to [the drug’s] label,” to “conclude that it was impossible for [the manufacturer] to comply with both federal and state requirements.” Slip op. at 15. The manufacturer defendant “offered no such evidence.” Id.


The majority also rejected the defendant’s argument that “requiring it to comply with a state-law duty to provide a stronger warning . . . would obstruct the purposes and objectives of federal drug labeling regulation.” Slip. op. at 17. The Court found in the history of Congress’s regulation of prescription drugs “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Id. at 18. The Court declined to defer to the FDA’s position, as stated in a preamble to a 2006 regulation governing prescription drug labels, that state tort claims like the plaintiff’s failure-to-warn claim threatened the agency’s “‘statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.’” Id. at 19 (quoting 71 Fed. Reg. 3922, 3935 (2006)). The Court perceived two problems with the agency’s position in the preamble. First, there was a “procedural failure,” because the agency had stated in its notice of proposed rulemaking that the promulgated rule would “not contain policies . . . that preempt State law.” Id. at 21 (internal quotation marks omitted). Second, the FDA’s position in the preamble “reversed the FDA’s own longstanding position” (which “disclaimed any attempt to pre-empt failure-to-warn claims”) without providing “a reasoned explanation” for the change. Id. The Court therefore rejected the defendant’s attempt to rely on Geier v. American Honda Motor Co., 529 U. S. 861 (2000), which held that automobile regulations promulgated by the Department of Transportation (DOT) pre-empted state-law torts. Id. at 23. In Geier, the Court explained, the DOT had conducted a formal rulemaking and issued a regulation bearing the force of law.


The Court “recognize[d] that some state-law claims might well frustrate the achievement of congressional objectives.” Slip op. at 25. But, given that “Congress has repeatedly declined to pre-empt state law” with respect to drug labeling, and “the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight,” the Court concluded that Wyeth was “not such a case.” Id. Because the defendant manufacturer possessed additional evidence concerning the risks of IV-push administration of Phenergan that would have permitted it to change the drug’s label and “comply with . . . state and federal law obligations,” and the plaintiff’s failure-to-warn claim did not “stand as an obstacle to the accomplishment of Congress’ purposes,” the Court affirmed the judgment for the plaintiff in state court below. Id.


Justice Breyer concurred in the Court’s opinion and wrote separately “to emphasize . . . that [the Court] ha[d] no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law.” See Wyeth v. Levine, No. 06-1249, slip. op. at 1 (Mar. 4, 2009) (Breyer, J., concurring). Going forward, he explained, “[t]he FDA may seek to determine whether and when state tort law acts as a help or a hindrance to achieving the safe drug-related medical care that Congress sought,” and it may “embody those determinations in lawful specific regulations describing . . . when labeling requirements serve as a ceiling as well as a floor.” Id. It is possible, Justice Breyer added, that such regulations “would have pre-emptive effect.” Id. at 2.


Justice Thomas concurred only in the judgment of the Court. He agreed that “the fact that the [FDA] approved the label for . . . Phenergan does not pre-empt the state-law judgment before the Court,” because federal law in these circumstances permitted the defendant manufacturer to change its label based upon newly analyzed information about the dangers of IV-push administration. See Wyeth v. Levine, No. 06-1249, slip. op. at 1 (Mar. 4, 2009) (Thomas, J., concurring). Justice Thomas refused, however, to join what he described as “the majority’s implicit endorsement of far-reaching implied pre-emption doctrines.” Id. at 2. To remain faithful to the Constitution, Justice Thomas concluded, pre-emption analysis “must turn on whether state law conflicts with the text of the relevant federal statute or with the federal regulations authorized by that text,” not on “whether a state statute is in tension with federal objectives.” Id. at 7. Justice Thomas consequently determined that he could “no longer assent to a doctrine that pre-empts state laws” on the ground that they “stan[d] as an obstacle to the accomplishment and execution of the full purposes and objectives of federal law.” Id. at 24 (internal quotation marks omitted).


Justice Alito, joined by the Chief Justice and Justice Scalia, dissented. Wyeth v. Levine, No. 06-1249, slip. op. at 1 (Mar. 4, 2009) (Alito, J., dissenting). He argued that “turning a common-law tort suit into a frontal assault on the FDA’s regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and [the Court’s] conflict pre-emption jurisprudence.” Id. at 2-3 (internal quotation marks omitted). He noted that ordinary principles of conflict pre-emption “turn solely on whether the State has upset the regulatory balance struck by the federal agency,” making it irrelevant whether Congress has enacted an express pre-emption provision. Id. at 6. Additionally, Justice Alito criticized the majority’s attempt to distinguish the Court’s decision in Geier, which he argued required the conclusion that plaintiff 's claims in this case are pre-empted. Id. at 18-23.


The FDA, Justice Alito emphasized, had focused on the safety of IV-push administration of Phenergan for 34 years. In approving a label that warned of the dangers associated with inadvertent intra-arterial injection, he concluded, the federal agency had struck a balance between the costs and benefits of administering the drug that juries are “ill-equipped” to make and that state tort suits would upset. Id. at 9-14, 23. Because the FDA “told Wyeth that Phenergan’s label renders its use ‘safe,’” and the State of Vermont, through application of “its tort law, said: ‘Not so,’” the dissent would have held that the state-law rule at issue was “squarely pre-empted.” Id. at 26.


In the end, although Wyeth found no pre-emption on the facts of the case before it, it does not foreclose pre-emption in all or even most drug cases. The Court’s opinion suggests that pre-emption may still be available, for example, in cases in which there is evidence that the FDA would not have approved a change to the drug’s label, where the FDA was actively involved in evaluating the potential risk identified by the plaintiff, where there is no new data or analysis that would justify an amended label pursuant to the CBE regulation, or if the FDA were to issue a pre-emptive regulation pursuant to its formal rulemaking authority. Nor does the decision extend beyond the FDCA context to foreclose other conflict preemption theories.